Failure to Warn Lawsuit Filed over Taxotere Hair Loss Following Breast Cancer Chemotherapy

Sanofi-Aventis faces another failure to warn lawsuit over the side effects of Taxotere, indicating that the chemotherapy drug caused a Louisiana woman to suffer permanent and disfiguring hair loss, which is not associated with other, equally effective breast cancer treatments. 

In a complaint (PDF) filed in the U.S. District Court for the Eastern District of Louisiana on October 18, Iris Guidry claims that the drug maker withheld information and warnings from consumers and the medical community about the risk that individuals may experience permanent hair problems from Taxotere.

While hair loss is a common side effect of chemotherapy, it is usually temporary and Sanofi-Aventis has suggested that hair typically grows back following use of Taxotere. However, Guidry indicates that since she underwent breast cancer chemotherapy treatments involving Taxotere in 2011, she has continued to experience hair loss side effects.

Guidry’s case joins a growing number of similar Taxotere failure to warn lawsuits filed in courts nationwide, each raising similar allegations that the drug maker did not adequately disclose the risks of permanent and disfiguring hair loss, providing false and misleading marketing statements.

Taxotere (docetaxel) is a high potency taxane-based cancer drug, which was introduced by Sanofi-Aventis in 1996 as a superior alternative to existing low-potency taxanes, such as Taxol. However, Guidry and other women nationwide now allege that the drug is actually no more effective at treating breast cancer, yet carries a risk of permanent hair loss, or alopecia, which has not been associated with low-potency taxanes.

While Taxotere warnings in several other countries were updated to include information about the risk of permanent baldness, that same information was not provided to American women and doctors.

“Defendants have chosen to withhold this information in the United States despite advising physicians, patients, and regulatory agencies in other countries, including the European Union and Canada, that Taxotere causes an increased risk of permanent disfiguring hair loss,” the lawsuit states. “Defendants instead continued to warn or advise physicians, healthcare providers, patients, and Plaintiff in the United States only with the generic, vague, and insufficient warning that ‘hair generally grows back’ after taking Taxotere.”

As early as 2005, studies found that women face a substantial risk of permanent hair loss with Taxotere, including findings that indicate one out of every 10 patients treated with Taxotere suffered hair loss that lasted up to 10 years and five months following chemotherapy, and in some cases longer.

Earlier this month the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered all Taxotere lawsuits filed in federal courts nationwide consolidated before U.S. District Judge Lance Africk in the Eastern District of Louisiana for pretrial proceedings.

It is likely that a small group of cases will be prepared for early “bellwether” trials to help gauge how juries may respond to certain evidence and expert testimony that will be repeated throughout the litigation. While the outcome of such early trials will not be binding in other cases, they may help the parties reach Taxotere settlements for women suffering permanent hair loss problems, avoiding the need for dozens of individual trails in courts throughout the U.S.